Dr. Tom Shimabukuro is the deputy director of the Immunization Safety Office at the US Centers for Disease Control and Prevention (CDC). The Immunization Safety Office conducts post-licensure safety monitoring of US vaccines.

Dr. Shimabukuro has also served as the Vaccine Adverse Event Reporting System (VAERS) team lead and acting team lead of the Vaccine Safety Datalink (VSD) team in the Immunization Safety Office. Prior to coming to the Immunization Safety Office, Dr. Shimabukuro coordinated pandemic influenza planning for CDC’s Immunization Services Division.

He received his medical degree from New York University. He did his internship at Emory University and preventive medicine residency at the Johns Hopkins University. Dr. Shimabukuro also completed a fellowship as an Epidemic Intelligence Service Officer at CDC. He is board certified in public health and general preventive medicine. ¹⁾

News Release 3-Sep-2021 No serious health effects linked to mRNA COVID-19 vaccines Study of 6.2 million patients by Kaiser Permanente and CDC researchers will continue for 2 years. Peer-Reviewed Publication

The study published September 2 in JAMA reports the first comprehensive findings of the Vaccine Safety Datalink (VSD), which studies patient records for 12 million people in 5 Kaiser Permanente service regions along with HealthPartners in Minneapolis, the Marshfield Clinic in Wisconsin, and Denver Health. The work is supported by the Centers for Disease Control and Prevention (CDC).

“These results from our safety surveillance are reassuring,” said lead author Nicola Klein, MD, PhD, director of the Kaiser Permanente Vaccine Study Center and principal investigator of the Vaccine Safety Datalink’s COVID-19 rapid cycle analysis.

“The world is relying on safe and effective vaccines to bring an end to the COVID-19 pandemic. The Vaccine Safety Datalink is ideally suited to carry out this important surveillance and we will continue to monitor the safety of all vaccines that protect against COVID-19,” added Dr. Klein, who is also a senior research scientist with the Kaiser Permanente Division of Research.

The study reported findings from mid-December 2020 through June 26, 2021. Some of the early findings had been summarized previously and reported at public meetings of the CDC’s Advisory Committee on Immunization Practices, though the JAMA article is the VSD’s first comprehensive report of its safety surveillance of the Pfizer and Moderna mRNA vaccines.

Patient medical records were searched electronically and analysts carried out chart reviews of specific health outcomes to verify the medical problem and to assess whether it started before or after vaccination.

Vaccine Safety Datalink researchers then applied statistical analysis to determine whether the number of incidents was above a certain threshold, or “signal.” They concluded that none of the target health outcomes reached the signal, though for some outcomes the findings were less precise because of small numbers of cases. The authors said VSD safety surveillance is ongoing, which will increase the precision of estimates for those outcomes.

“The results of this study are a great example of how seriously CDC takes vaccine safety, and how thorough and transparent we are in our safety monitoring efforts,” said Tom Shimabukuro, MD, leading vaccine safety for the COVID-19 response and the deputy director of CDC’s Immunization Safety Office. “It is our top priority to do the science and communicate quickly and clearly with healthcare providers and the public, as COVID-19 vaccines continue to undergo the most intensive safety monitoring in U.S. history. Getting vaccinated remains the best way to protect yourself and your loved ones against a virus that has taken millions of lives.”

The VSD’s rapid-cycle analysis for the mRNA COVID-19 vaccines will continue tracking newly vaccinated patients for at least 2 years. The VSD, established in 1990 and led by the CDC, Kaiser Permanente, and other health care systems, is the nation’s premier active surveillance system for vaccine safety.

Patient medical records were searched electronically and analysts carried out chart reviews of specific health outcomes to verify the medical problem and to assess whether it started before or after vaccination.

Vaccine Safety Datalink researchers then applied statistical analysis to determine whether the number of incidents was above a certain threshold, or “signal.” They concluded that none of the target health outcomes reached the signal, though for some outcomes the findings were less precise because of small numbers of cases. The authors said VSD safety surveillance is ongoing, which will increase the precision of estimates for those outcomes. ²⁾